BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3843800 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09973
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA05SC4, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE CAUSE OF THE EVENT WAS UNKNOWN. THE DEVICE WAS NOT ON BUT THE PATIENT REPORTING PAIN. A (KUB) KIDNEY, URETERS AND BLADDER MRI/X-RAY/CTSCAN WAS PERFORMED ON (B)(6) 2014 AND NOTED AS NORMAL. IT WAS NOTED ¿MULTIPLE¿ UNDER REVISION/SURGICAL DESCRIPTION/RESULTS. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND NO INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER REPORTS A SHOCKING OR JOLTING SENSATION. THE CALLER WAS THE PATIENT'S "PERSONAL ASSISTANT" AND ASKED IF IT WAS "NORMAL TO HAVE A VERY HIGH LEVEL SHOCK RANDOMLY AT ANY TIME?" CALLER STATES THAT THE PATIENT HAS RANDOM SHOCKS DURING VARIOUS ACTIVITIES RANGING FROM SITTING, STANDING AND ITS SOMETIMES AT NIGHT AND SOMETIMES AT LUNCH. AFTER SPEAKING WITH THE PATIENT, THE CALLER SAYS THAT HE WAS UNDER THE IMPRESSION THAT THIS SHOCKING HAS BEEN HAPPENING A LOT, BUT THE PATIENT TOLD HIM THAT THIS ONLY HAPPENED ONCE DURING LUNCH "SOMETIME LAST WEEK". CALLER SAID THAT HE THOUGHT SHE "WAS GETTING BIG BITES OFF AND ON BUT I GUESS SHE IS NOT.¿ THE CALLER REPORTS AN OVERSTIMULATION SENSATION. CALLER ASKED "HOW OFTEN DO THEY FIRE OFF"? THE CALLER SAYS THAT 'RIGHT NOW IF YOU HAVE THE DEVICE TURNED HIGH ENOUGH, IT HAPPENS IN SECONDS IT¿S NOT LIKE ITS ONCE AN HOUR. AS YOU INCREASE THE INTENSITY THAT PULSE GETS MORE INTENSE". IT WAS REVIEWED IF THE PATIENT WAS FEELING UNCOMFORTABLE FROM THE THERAPY SHE SHOULD SPEAK WITH HER HCP (HEALTHCARE PROVIDER). THE CALLER SAID THAT "ONE DOCTOR SAID SHE SHOULD REALLY FEEL IT AND THE OTHER DOCTOR SAID SHE SHOULD ONLY FEEL IT SLIGHTLY. SHE HAS IT TURNED DOWN A LOT RIGHT NOW BUT SHE DOES GET THESE VERY SHARP BITES FROM TIME TO TIME AND I GUESS WHEN IT HAPPENED LAST WEEK IT WAS TURNED DOWN LOW BUT SHE SAYS SHE DOES GET VERY INTENSE PULSES AND BITES FROM TIME TO TIME".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT HAD SURGERY ON (B)(6) 2013. THE OPERATIVE NOTE STATED THAT THEY "REPLACED NON-FUNCTIONING BATTERY AND NON-FUNCTIONAL LEAD." THE HEALTHCARE PROVIDER SAID THE ENTIRE SYSTEM WAS REMOVED AND RE-IMPLANTED. THE HEALTHCARE PROVIDER WAS ASKED IF THERE WERE ANY DEVICE MALFUNCTIONS SEEN OR SUSPECTED. THE HEALTHCARE PROVIDER SAID SHE DID NOT KNOW AND THAT SHE WOULD NEED TO HAVE THEIR PA (PHYSICIAN ASSISTANCE) CALL BACK TO ANSWER THOSE QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321305 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention